Ezogabine

This drug, Potiga or ezogabine, is no longer available in the United States

This drug is important because it prevents seizures in a new way different from currently existing antiseizure medications.

Potiga

Tablet

50 mg

200 mg

300 mg

400 mg

Used to treat

Temporal Lobe Epilepsy

Focal Impaired Awareness or Complex Partial Seizures

Refractory Seizures

Secondarily Generalized Seizures or Bilateral Tonic Clonic Seizure

Focal Aware or Simple Partial Seizure

Forms

Potiga is sold in the United States by GSK/Valeant Pharmaceuticals. The name or appearance may be different in various countries, but the dose measured in milligrams, abbreviated “mg” usually will be the same. These descriptions apply to the U.S. versions:

Dosing

See package insert for more complete information.

How to take and store Ezogabine?

Follow your doctor’s directions. Call if you have any questions. Usually, your doctor will start by taking one tablet, either 100 mg two times each day or less, 50 mg two pills three times a day. After a while, the doctor may gradually increase the dosage up to 1200 mg per day to get better control of your seizures. To take that amount, you probably would take up to the 400 mg size tablets three times a day.

Most people swallow the tablets whole to avoid a bitter taste. People who cannot swallow the tablet may be able to crush the tablet and mix it with food. It is OK to take Potiga either with food or without food, but it is a good idea to take it the same way every time. Taking Potiga with food does not change how much Potiga your body absorbs, but it does slow down the absorption a bit.

Be careful if the doctor writes a new prescription using a different kind of pill. Make sure that the total daily dose is the same before and after. Do not automatically continue to use the same number of pills as before.

Do not take more than the doctor prescribes. If you think you have used one or two extra tablets, call your doctor for advice. For a large overdose, call your local poison control center or emergency room right away, unless you have special instructions from the doctor.

Do not stop taking Potiga or change the amount you use without talking to the doctor first. Stopping any seizure medicines all at once can cause serious problems.

All forms of Potiga should be stored at room temperature away from light and humidity. Do not keep the pills in the bathroom if it is damp there. Of course, keep all Potiga out of the reach of children.

What if I forget?

If you forget a dose of Potiga, take it as soon as you remember. If it is almost time for the next dose, delay that dose for a few hours instead of taking two doses very close together. Then, go back to the regular schedule. If you are not sure about what to do, call the doctor’s office for more advice.

Do your best to follow the doctor’s directions. If you forget doses often, it may be a good idea to get a special pill box or watch with an alarm to remind you.

Taking the right amount of seizure medicine on time every single day is the most important step in preventing seizures.

With regards to urinary retention, Potiga did cause urinary retention in clinical trials and was reported within the first six months of treatment, but was also observed at later times. It was seen in approximately 2% of patients treated in the drug studies. Therefore, because of the increased risk of urinary retention on Potiga, urologic symptoms need to be carefully monitored, particularly for patients with benign prostatic hypertrophy, patients who are unable to communicate clinical symptoms, or patients who use other medications that can affect urination. In these patients a comprehensive evaluation of urological symptoms prior to and during treatment with Potiga may be appropriate.

Confusional states, psychotic symptoms and hallucinations were reported more frequently as side effects in patients treated with Potiga than in those on placebo. The psychiatric symptoms in the mass majority of patients resolved within seven days of stopping the drug. A rapid increase at greater than the recommended doses appears to increase the risk of these side effects.

Potiga increases the chances for dizziness and tiredness. Dizziness is reported in 23% of patients treated with Potiga, but yet only 9% in people treated with a placebo (a sugar pill). Sleepiness was reported in 22% with Potiga and 12% with a sugar pill. Most of these side effects were considered mild to moderate in intensity.

As with all seizure drugs it is important to always be wary of issues of depression and / or suicidal thoughts associated with seizure medication. This is also the case for Potiga. Because of this it is important that one always be very cautious when prescribing this drug to see if there is any change in mood or behavior. Any change in these behaviors or vocalizing a sense that something is happening with regards to self harm would lead us to discontinue the medication.

As with all seizure drugs when Potiga is stopped it should be withdrawn gradually in order to minimize the potential of increased seizure frequency. Potiga needs to be reduced over a period of at least three weeks in order to safely eliminate the medication. One should never stop the medication cold.

What are the most serious side effects of Ezogabine?

In some rare cases some people taking the drug have reported bluish discoloration of the skin and nails. In addition, some individuals have reported visual loss and changes. Please talk to your doctor if any of these problems are seen so these can be watched over time.

FDA review of additional safety information (as of June 2015) does not indicate that the pigment changes in the retina observed in some patients affect vision. Skin discoloration sometimes seen with the use of Potiga appears to be a cosmetic effect and does not appear to be associated with more serious adverse effects.

The FDA expects that long-term observational studies will give more information on whether pigment changes in the retina caused by Potiga can lead to vision loss or other long-term side effects. These required studies should provide more information on the relationship between pigment changes in the retina and skin discoloration.

Impact of Ezogabine on bone health

See package insert. At this point, there is little information on the impact of Potiga on bone health. It is important to talk to your doctor about any concerns you may have about this issue.

What else is Ezogabine used for?

See package insert.

Who should not take Ezogabine?

See package insert.

Can Ezogabine be taken with other medicines?

See package insert.

What are the effects of Ezogabine on Children?

See package insert.

If a woman takes Ezogabine during pregnancy will it hurt the baby?

Ezogabine is considered pregnancy category C. There are no adequate studies in pregnant women to know for certain what effect Potiga will have on an unborn child. Potiga should be used during pregnancy only if the potential benefit justifies its potential risk to the fetus. In animal studies, doses associated with maternal plasma exposures to Ezogabine and its main metabolite did produce developmental toxicity when administered in pregnant rats and rabbits. The maximum doses evaluated were limited by maternal toxicity. Therefore, it is unclear what the effects on humans are. It is important that if one is pregnant while taking this medication that one should enroll in a pregnancy registry, such as the North American Antiepileptic Drug Pregnancy Registry, in order to help gather information on this topic. With regards to nursing mothers, it is not known whether Ezogabine is excreted in human milk. However, Potiga and Ezogabine are present in the milk of lactating rats. Because of the potential for side effects in nursing infants from Potiga, a decision should be made whether to discontinue nursing or discontinue the drug, depending on which is the more important risk. This is a discussion for the patient with their doctor.

With regards to children, the safety and effectiveness of Potiga in patients under 18 years of age have not been established. Further studies are clearly needed in order to understand its impact on children.

As opposed to older adults, there are an insufficient number of older patients enrolled in these trials to determine its safety and efficacy. One needs to adjust the dose of medications in patients if 65 years and older. Elderly men with symptomatic benign prostatic hypertrophy could be at increased risk for urinary retention. Patients with kidney and liver disease should have dose adjustments made in order to account for these issues.

What are the effects of Ezogabine on Seniors

See package insert.

What are the dose ranges for Ezogabine?

Potiga reduced seizure frequency at 600 mg., 900 mg., and 1200 mg. per day. The reduction in seizure frequency was 27% for 600 mg. of Potiga; 25% for 900 mg.; and up to 24% seizure reduction for 1200 mg. per day. These were all found to be statistically significant for all of these doses compared to a placebo.

Special Concerns for Ezogabine

See package insert.

Read the package insert of Ezogabine

In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.

You can also read these documents (also called "prescribing information") online. The U.S. package insert for Potiga (ezogabine) is found at: